TRIGLYCERIDES REAGENT SYSTEM— 510(k) K843832

Name: FDA 510(k) clearance K843832
Creator: U.S. Food and Drug Administration
Published: 1984-11-27

Substantially Equivalent

Fermco Biochemics, Inc.

FDA 510(k) clearance K843832 for TRIGLYCERIDES REAGENT SYSTEM, Substantially Equivalent on 1984-11-27. Applicant: Fermco Biochemics, Inc.. Device class: 1.

Clearance details

Applicant: Fermco Biochemics, Inc.
Product code: Code CDT
Device class: Class 1
Regulation: 21 CFR 862.1705
Advisory panel: Clinical Chemistry
Date received: 1984-10-01
Decision date: 1984-11-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elk Grove Village, IL, US

Download summary PDF View on FDA.gov ↗

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